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Immunotherapy for the Treatment of Advanced Solid Tumor

NCT03658785 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.

Conditions

Interventions

BIOLOGICAL

TIL

On day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)

DRUG

Aldesleukin

IL-2 125,000 IU/kg/day IV (based on total body weight) beginning within 24 hours of cell infusion and continuing for up to 2 weeks

DRUG

Cyclophosphamide

On day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.

DRUG

Fludarabine

Days -5 to -1: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Hui Wang, MD · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658785 on ClinicalTrials.gov